Clobetasol cream for topical use

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

clobetasol (clobetasol propionate)

Fáanlegur frá:

Arpimed LLC

ATC númer:

D07AD01

INN (Alþjóðlegt nafn):

clobetasol (clobetasol propionate)

Skammtar:

0,5mg/g

Lyfjaform:

cream for topical use

Einingar í pakka:

15g aluminium tube

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2023-11-07

Vara einkenni

SUMMARY PRODUCT CHARACTERISTIC (SPC)
CLOBETASOL
0.05% CREAM FOR EXTERNAL USE
1. NAME OF THE MEDICINAL PRODUCT – CLOBETASOL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Clobetasol 0.05% cream contains:
_ACTIVE INGREDIENT:_ clobetasol propionate – 0.5 mg;
_For a full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM
Cream.
White odorless cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clobetasol is a very potent topical corticosteroid indicated for
adults, elderly and children over 1
year for the short term treatment only of more resistant inflammatory
and pruritic manifestations of
steroid
responsive
dermatoses
unresponsive
to
less
potent
corticosteroids.
These
include
the
following:
- Psoriasis (excluding widespread plaque psoriasis)
- Recalcitrant dermatoses
- Lichen planus
- Discoid lupus erythematosus
- Other skin conditions which do not respond satisfactorily to less
potent steroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Clobetasol propionate belongs to the most potent class of topical
corticosteroids (Group IV) and
prolonged use may result in serious undesirable effects (see section
4.4). If treatment with a local
corticosteroid is clinically justified beyond 4 weeks, a less potent
corticosteroid preparation should
be considered. Repeated but short courses of clobetasol propionate may
be used to control
exacerbations (see details below).
Route of administration: Cutaneous
Creams are especially appropriate for moist or weeping surfaces.
_ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR _
Apply thinly and gently rub in using only enough to cover the entire
affected area once or twice a
day until improvement occurs (in the more responsive conditions this
may be within a few days),
then reduce the frequency of application or change the treatment to a
less potent preparation. Allow
adequate time for absorption after each application before applying an
emollient.
Repeated short courses of clobetasol propionate may be used to control
exacerbations.
In more resistant lesions, especi